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Monoclonal Antibodies
IOV-4001 for Melanoma and Lung Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Iovance Biotherapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must be assessed as having at least one resectable lesion.
Participants who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Must not have
Participants who have symptomatic untreated brain metastases.
Participants who have another primary malignancy within the previous 3 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year or depending on when the recommended phase 2 dose is determined
Awards & highlights
Summary
This trial is testing IOV-4001, a modified immune cell treatment, in adults with advanced melanoma or lung cancer. The treatment aims to improve the ability of the patient's own immune cells to attack cancer by disabling a gene that helps cancer hide.
Who is the study for?
Adults with advanced melanoma or non-small-cell lung cancer (NSCLC) that can't be surgically removed. They must have had certain prior treatments, good organ function, and no untreated brain metastases or recent live vaccines. Participants need a measurable lesion for the study and agree to use effective birth control.
What is being tested?
The trial is testing IOV-4001 infusion's effectiveness and safety in treating unresectable/metastatic melanoma or advanced NSCLC. It will involve adults who meet specific health criteria and have received previous therapies relevant to their cancer stage.
What are the potential side effects?
While not explicitly listed here, side effects may include typical reactions to infusions such as pain at the injection site, fever, chills, nausea, fatigue, allergic reactions; organ inflammation due to immune response; increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have at least one tumor that can be surgically removed.
Select...
I am fully active or can carry out light work.
Select...
I have been diagnosed with advanced melanoma or non-small cell lung cancer.
Select...
I have received platinum-based chemotherapy.
Select...
I have at least one tumor that can be measured and was removed for a specific treatment.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have brain metastases that haven't been treated and are causing symptoms.
Select...
I have had another type of cancer in the last 3 years.
Select...
My melanoma originates from the eye.
Select...
I need more than 10 mg/day of prednisone or an equivalent steroid.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year or depending on when the recommended phase 2 dose is determined
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year or depending on when the recommended phase 2 dose is determined
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Phase 2: Objective Response Rate (ORR)
Phase I: Safety of IOV-4001
Secondary study objectives
CR Rate
Disease Control Rate (DCR)
Duration of Response (DOR)
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment1 Intervention
Participants with Stage III or IV non-small-cell lung cancer
Group II: Cohort 1Experimental Treatment1 Intervention
Participants with unresectable or metastatic melanoma
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for melanoma, particularly cellular therapies and immunotherapies, work by harnessing the body's immune system to target and destroy cancer cells. Cellular therapies, such as tumor-infiltrating lymphocytes (TILs), involve extracting immune cells from the patient, expanding them in the lab, and reinfusing them to attack the melanoma.
Immunotherapies, like checkpoint inhibitors (e.g., nivolumab and ipilimumab), block proteins that prevent immune cells from attacking cancer, thereby enhancing the immune response against melanoma cells. These treatments are significant for melanoma patients as they offer targeted approaches that can lead to durable responses and potentially long-term remission, especially in cases where traditional therapies have failed.
Find a Location
Who is running the clinical trial?
Iovance Biotherapeutics, Inc.Lead Sponsor
23 Previous Clinical Trials
1,772 Total Patients Enrolled
Iovance Biotherapeutics Study TeamStudy DirectorIovance Biotherapeutics
4 Previous Clinical Trials
940 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have melanoma, worsened within 12 weeks after anti-PD-1/PD-L1 treatment, and received BRAF/MEK inhibitors if BRAF positive.I have at least one tumor that can be surgically removed.I have received specific treatments based on my group assignment.My organs are functioning well.I have not had a live vaccine within the last 28 days.You may need to take a breathing test.I have brain metastases that haven't been treated and are causing symptoms.I am fully active or can carry out light work.I received my last dose of anti-PD-1/PD-L1 therapy less than 12 weeks ago.I have had another type of cancer in the last 3 years.My cancer worsened within 12 weeks after my last anti-PD-1/PD-L1 treatment.I have been diagnosed with advanced melanoma or non-small cell lung cancer.I have had an organ transplant or cell therapy after chemo in the last 20 years.I have received platinum-based chemotherapy.My melanoma originates from the eye.You need to have a test to check how well your heart is working.I need more than 10 mg/day of prednisone or an equivalent steroid.I have at least one tumor that can be measured and was removed for a specific treatment.You have a condition that weakens your immune system from birth.I am fully active or restricted in physically strenuous activity but can do light work.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1
- Group 2: Cohort 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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